MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0605510

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Extravasation (1842); Perforation of Vessels (2135); Swelling/ Edema (4577)

Event Date 08/04/2021

Event Type  Injury  

Manufacturer Narrative

The catalog number has not been cleared in the us but is similar to the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 10/2022).

Event Description

It was reported that after port placement procedure, a perforation was allegedly noted in supraclavicular right upstream of the portion intra-vascular within the sub clavicular soft tissues.The patient status was unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but3 is similar to the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ti powerport low profile attached to a catheter were returned for evaluation and one medical image was provided for review.Gross, microscopic visual and function testing were performed.Based on the provided image review, the investigation is inconclusive for the reported perforation and edema as no areas of active extravasation and perforation were visualized.However, based on the returned sample analysis, the investigation is confirmed for the identified fracture and leak issue a longitudinal split was noted on the catheter approximately 8.2cm from the distal end of the cath-lock.Upon infusion of the port body with attached catheter segment, a leak from the longitudinal split was observed.Furthermore, the clinical conditions alleged in the complaint as the exact circumstances at the time of reported event cannot be replicated and cannot be confirmed from the returned sample.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: (expiry date: 10/2022).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that approximately three years post port placement procedure, a perforation was allegedly noted in supraclavicular right upstream of the portion and edema above the right clavian.It was further reported that the device was removed.The patient status was unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ti powerport low profile attached to a catheter were returned for evaluation.One medical image and medical record were provided for review.Gross, microscopic visual and function testing were performed.The investigation is confirmed for the reported fracture, fluid leak and edema.According to the medical record, approximately two years and nine months post port implantation, patient had reaction during infusion of navelbine.Patient experienced hot flush, sweating, supra-clavicular edema, that was probably collection and leak.Subsequently pac opacification study was performed for right clavicular edema during chemotherapy.Hubert needle puncture of the pac chamber, with good positioning confirmed in fluoroscopy.Slow opacification showed leakage and extravasation of contrast material along the catheter tubing, just before its passage intravascularly into the vein, with opacification of the right supraclavicular subcutaneous soft tissue.Further, the study was confirmed that perforation of the right supraclavicular pac catheter, upstream of its intravascular portion, with extravasation within the supraclavicular soft tissues.Pac was not usable due to extravasation of navelbine.Next day, patient presented for port removal.Eventually after removal of port, a computed tomography (ct) revealed no infiltration or organized collection visible on the old route of the port-a-cath.However, based on the returned sample analysis, a longitudinal split was noted on the catheter approximately 8.2cm from the distal end of the cath-lock.Upon infusion of the port body with attached catheter segment, a leak from the longitudinal split was observed.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 10/2022), g3, h6(method).H11: h6 (patient).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.

Event Description

It was reported that approximately three years post port placement procedure, a perforation was allegedly noted in supraclavicular right upstream of the portion and edema above the right clavian.It was further reported that the device was removed.The patient status was unknown.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12419324
• MDR Text Key: 271693070
• Report Number: 3006260740-2021-03683
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025969
• UDI-Public: (01)00801741025969
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0605510
• Device Catalogue Number: 0605510CE
• Device Lot Number: RECU2412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/11/2021; 02/13/2022
• Supplement Dates FDA Received: 09/15/2021; 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Female